DESCRIZIONE/REQUISITI |
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At Genmab, we’re committed to building
extra[not]ordinary futures together, by
developing antibody products and pioneering,
knock-your-socks-off therapies that change
the lives of patients and the future of
cancer treatment and serious diseases. From
our people who are caring, candid, and
impact-driven to our business, which is
innovative and rooted in science, we believe
that being proudly unique, determined to be
our best, and authentic is essential to
fulfilling our purpose.
The Role & Department
Are you inspired to work in a company with
ambitious goals, exciting clinical
development programs, and highly enthusiastic
colleagues? Our vision by 2030 is that
Genmab’s knock-your-socks-off “KYSO” antibody
medicines will transform the lives of people
with cancer and other serious diseases. Do
you want to safeguard patients and ensure
quality compliance in all aspects within GCP?
– Then seize this great career opportunity!
We are looking for a highly motivated QA
Senior Manager with at least 5 years of
experience within GCP and/or GCLP. You are
likely already an experienced lead auditor
with the capabilities to train other auditors
within GCP/GCLP. You are familiar with
internal process audits and CRO audits of
clinical data processing in different IT
systems. You have a deep knowledge of the
requirements related to computerized systems
in clinical trials and you understand the
impact.
As QA Senior Manager you will have in-depth
and strong scientific expertise within
quality assurance and all regulatory
requirements related to clinical development.
You will have strong analytical skills, high
quality standards, and attention to detail as
well as the ability to apply these qualities
into a strategic context that enables you to
identify solutions within agreed deadlines.
You will be working in a global team with QA
colleagues located in the US, the
Netherlands, Japan and Denmark. Furthermore,
you will be part of a strong cross-functional
collaboration throughout the company.
Key responsibilities include:
- You will plan, conduct, report and follow
up on quality audits within the GCP regulated
areas.
- Mentor on-boarding QA colleagues as well as
experienced Lead auditors to increase the
competency level across the global QA GCP &
PV team.
- You will develop and maintain the audit
strategies in collaboration with the Team
Lead.
- You will coordinate and lead GCP inspection
readiness activities for FDA, EMA and PMDA
inspections.
- You will participate in inspections and
audits performed by our partners.
- Participate in, or drive the development,
maintenance, and improvement of the Genmab
QMS with focus on GCP and GCLP requirements.
- Conduct and coordinate internal GCP
training.
- Deliver GCP advisory expertise both within
the company and to external vendors.
Requirements:
- MSc in Natural Science or similar and at
least 5 years of profound experience within
GCP and GCLP.
- Experienced Lead Auditor within GCP and/or
GCLP, preferably with in-depth knowledge
related to internal process audits and CRO
audits of clinical data processing in
different IT systems.
- Practical proficiency in the use and
understanding of Veeva Vault QMS.
- Experience with the due diligence process
and qualification of new vendors or services.
- Considered to be a Domain Expert within GCP
and/or GCLP by peers with a strong interest
and ability to educate others.
Moreover, you meet the following personal
requirements:
- Strong analytical skills with an eye for
detail combined with the ability to extract
and apply into a tactical and strategic
context.
- To strive and thrive in a setting with
multiple complex tasks and shifting
priorities.
- Pro-active and open-minded, a dedicated
team player with excellent oral and written
communication skills.
This role can be located in Copenhagen,
Denmark, or Utrecht, the Netherlands, or
Princeton, New Jersey, U.S.
The role is hybrid, with an expectation of
60% on-site presence, combined with the
option to work remotely two days per week on
average.
About You
You are passionate about our purpose and
genuinely care about our mission to transform
the lives of patients through innovative
cancer treatment
You bring rigor and excellence to all that
you do. You are a fierce believer in our
rooted-in-science approach to problem-
solving
You are a generous collaborator who can work
in teams with diverse backgrounds
You are determined to do and be your best and
take pride in enabling the best work of
others on the team
You are not afraid to grapple with the
unknown and be innovative
You have experience working in a fast-
growing, dynamic company (or a strong desire
to)
You work hard and are not afraid to have a
little fun while you do so
Locations
Genmab leverages the effectiveness of an
agile working environment, when possible, for
the betterment of employee work-life balance.
Our offices are designed as open, community-
based spaces that work to connect employees
while being immersed in our state-of-the-art
laboratories. Whether you’re in one of our
collaboratively designed office spaces or
working remotely, we thrive on connecting
with each other to innovate.
About Genmab
Genmab is an international biotechnology
company with a core purpose guiding its
unstoppable team to strive towards improving
the lives of patients through innovative and
differentiated antibody therapeutics. For
more than 20 years, its passionate,
innovative and collaborative team has
invented next-generation antibody technology
platforms and leveraged translational
research and data sciences, which has
resulted in a proprietary pipeline including
bispecific T-cell engagers, next-generation
immune checkpoint modulators, effector
function enhanced antibodies and antibody-
drug conjugates. To help develop and deliver
novel antibody therapies to patients, Genmab
has formed 20+ strategic partnerships with
biotechnology and pharmaceutical companies.
By 2030, Genmab’s vision is to transform the
lives of people with cancer and other serious
diseases with Knock-Your-Socks-Off (KYSO™)
antibody medicines.
Established in 1999, Genmab is headquartered
in Copenhagen, Denmark with locations in
Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and
inclusion
We are committed to fostering workplace
diversity at all levels of the company and we
believe it is essential for our continued
success. No applicant shall be discriminated
against or treated unfairly because of their
race, color, religion, sex (including
pregnancy, gender identity, and sexual
orientation), national origin, age,
disability, or genetic information. Learn
more about our commitments on our website.
Genmab is committed to protecting your
personal data and privacy. Please see our
privacy policy for handling your data in
connection with your application on our
website https://www.genmab.com/privacy.
Please note that if you are applying for a
position in the Netherlands, Genmab’s policy
for all permanently budgeted hires in NL is
initially to offer a fixed-term employment
contract for a year, if the employee performs
well and if the business conditions do not
change, renewal for an indefinite term may be
considered after the fixed-term employment
contract.
How to apply: directly at this website
https://genmab.wd3.myworkdayjobs.com/en-
US/Genmab_Careers_Site/details/Senior-
Manager--GCP-PV_R10145?
locationCountry=49ab063f422741e2aef271de00efe
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